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- NCIT_C72905 IAO_0000115 "A new drug application submitted under section 505(b)(1) of the CFR Title 21, Chapter 9 (FEDERAL FOOD, DRUG, AND COSMETIC ACT) for a drug for which the investigations described in section 505(b)(1)(A) of the act and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. An applicant should submit a 505(b)(2) application if approval of an application will rely to any extent on published literature, or on the Agency's previous finding of safety and/or effectiveness for a drug." @default.
- NCIT_C72905 NCIT_NHC0 "C72905" @default.
- NCIT_C72905 NCIT_P106 "Intellectual Product" @default.
- NCIT_C72905 NCIT_P108 "505(b)(2) New Drug Application" @default.
- NCIT_C72905 NCIT_P207 "C2346546" @default.
- NCIT_C72905 NCIT_P366 "_505_b_2_New_Drug_Application" @default.
- NCIT_C72905 normalizedInformationContent "95.413332725061409" @default.
- NCIT_C72905 referenceCount "2" @default.
- NCIT_C72905 hasExactSynonym "505(b)(2) NDA" @default.
- NCIT_C72905 hasExactSynonym "505(b)(2) New Drug Application" @default.
- NCIT_C72905 type Class @default.
- NCIT_C72905 isDefinedBy ncit.owl @default.
- NCIT_C72905 label "505(b)(2) New Drug Application" @default.
- NCIT_C72905 subClassOf NCIT_C19498 @default.
- NCIT_C72905 subClassOf NCIT_C20181 @default.
- NCIT_C72905 subClassOf NCIT_C25198 @default.
- NCIT_C72905 subClassOf NCIT_C60755 @default.
- NCIT_C72905 subClassOf NCIT_C70868 @default.
- NCIT_C72905 subClassOf NCIT_C70880 @default.
- NCIT_C72905 subClassOf NCIT_C72899 @default.
- NCIT_C72905 subClassOf NCIT_C72905 @default.
- NCIT_C72905 subClassOf NCIT_C73110 @default.
- NCIT_C72905 subClassOf NCIT_C73111 @default.
- NCIT_C72905 subClassOf NCIT_C97331 @default.